Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation

Karl Heinz Kuck, Josep Brugada, Alexander Fürnkranz, Andreas Metzner, Feifan Ouyang, K. R Julian Chun, Arif Elvan, Thomas Arentz, Kurt Bestehorn, Stuart J. Pocock, Jean Paul Albenque, Claudio Tondo

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation. Radiofrequency ablation is the most common method, and cryoballoon ablation is the second most frequently used technology. METHODS: We conducted a multicenter, randomized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation. The primary efficacy end point in a time-to-event analysis was the first documented clinical failure (recurrence of atrial fibrillation, occurrence of atrial flutter or atrial tachycardia, use of antiarrhythmic drugs, or repeat ablation) following a 90-day period after the index ablation. The noninferiority margin was prespecified as a hazard ratio of 1.43. The primary safety end point was a composite of death, cerebrovascular events, or serious treatment-related adverse events. RESULTS: A total of 762 patients underwent randomization (378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation). The mean duration of follow-up was 1.5 years. The primary efficacy end point occurred in 138 patients in the cryoballoon group and in 143 in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 34.6% and 35.9%, respectively; hazard ratio, 0.96; 95% confidence interval [CI], 0.76 to 1.22; P

Original languageEnglish
Pages (from-to)2235-2245
Number of pages11
JournalNew England Journal of Medicine
Volume374
Issue number23
DOIs
Publication statusPublished - Jun 9 2016

ASJC Scopus subject areas

  • Medicine(all)

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    Kuck, K. H., Brugada, J., Fürnkranz, A., Metzner, A., Ouyang, F., Chun, K. R. J., Elvan, A., Arentz, T., Bestehorn, K., Pocock, S. J., Albenque, J. P., & Tondo, C. (2016). Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. New England Journal of Medicine, 374(23), 2235-2245. https://doi.org/10.1056/NEJMoa1602014